Kraj: Izrael
Język: angielski
Źródło: Ministry of Health
SOLIFENACIN SUCCINATE
CTS LTD
G04BD08
FILM COATED TABLETS
SOLIFENACIN SUCCINATE 5 MG
PER OS
Required
ASTELLAS PHARMA EUROPE B.V, THE NETHERLANDS
SOLIFENACIN
SOLIFENACIN
Vesicare is indicated for symptomatic treatment of urge incontinence and/or increased urinary frequency and urgency as may occur in patients with overactive bladder syndrome.
2021-11-30
[לוגו מדינת ישראל] [http://www.gov.il/] [http://www.gov.il/] [לוגו משרד הבריאות] [לוגו משרד הבריאות] [*5400] [http://www.health.gov.il/PniyotHazibur/Pages/CallCenter.aspx] [http://www.health.gov.il/PniyotHazibur/Pages/CallCenter.aspx] הציבור הרחב עסקים ומוסדות עובדים בבריאות חפש מידע תפריט * [סגירה] סגור * דף הבית [http://www.health.gov.il/] * אודות * אודות המשרד [http://www.health.gov.il/About/Pages/about_us.aspx] * תוכנית עבודה [http://www.health.gov.il/About/Pages/Agenda.aspx] * תקציב המשרד [http://www.health.gov.il/About/Pages/budget.aspx] * תרשים מבנה ארגוני [http://www.health.gov.il/About/Pages/OrganizationalStructureDiagram.aspx] * בעלי תפקידים [http://www.health.gov.il/About/Phonebook/Pages/PhoneBook.aspx] * יחידות המשרד [http://www.health.gov.il/UnitsOffice/Pages/UnitsList.aspx] * לשכות הבריאות [http://www.health.gov.il/About/Phonebook/Pages/PhoneBook.aspx?tab=3] * אמנת שירות [http://www.health.gov.il/About/sla/Pages/default.aspx] * אותות ופרסים [http://www.health.gov.il/About/Awards/Pages/mifal.aspx] * פרוייקטים תשתיתיים [http://www.health.gov.il/About/projects/shared_medical_info/Pages/default.aspx] * דרושים [http://www.health.gov.il/About/Careers/Pages/default.aspx] * מנכ"לי משרד הבריאות לדורותיהם [http://www.health.gov.il/About/Pages/GeneralManegerHistory.aspx] * יחידות המשרד * יחידות המשרד [http://www.health.gov.il/UnitsOffice/Pages/UnitsList.aspx] * לשכות הבריאות [http://www.health.gov.il/UnitsOffice/LB/Pages/default.aspx] * וועדות ומועצות [http://www.health.gov.il/Services/Committee/Pages/CommitteeList.aspx] * נושאים * בריאות הנפש [http://www.health.gov.il/Subjects/mental_health/Pages/default.aspx] * בריאות הסביבה [http://www.health.gov.il/Subjects/Environmental_Health/ Przeczytaj cały dokument
- 1 - SUMMARY OF PRODUCT CHARACTERISTICS (SMPC) 1. NAME OF THE MEDICINAL PRODUCT Vesicare ® 5 mg, film-coated tablet Vesicare ® 10 mg, film-coated tablet 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Vesicare 5 mg film-coated tablet: Each tablet contains 5 mg solifenacin succinate, corresponding to 3.8 mg solifenacin. Vesicare 10 mg film-coated tablet: Each tablet contains 10 mg solifenacin succinate, corresponding to 7.5 mg solifenacin. For a full list of excipients, see Section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablets. Vesicare 5 mg film-coated tablet: Each 5 mg tablet is a round, light-yellow tablet marked with the logo and “150” on the same side. Vesicare 10 mg film-coated tablet: Each 10 mg tablet is a round, light-pink tablet marked with the logo and “151”on the same side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Symptomatic treatment of urge incontinence and/or increased urinary frequency and urgency as may occur in patients with overactive bladder syndrome. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY _Adults, including the elderly _ The recommended dose is 5 mg solifenacin succinate once daily. If needed, the dose may be increased to 10 mg solifenacin succinate once daily. _paediatric population _ The safety and efficacy of Vesicare in children have not yet been established. Therefore, Vesicare should not be used in children. - 2 - _Patients with renal impairment _ No dose adjustment is necessary for patients with mild to moderate renal impairment (creatinine clearance > 30 ml/min). Patients with severe renal impairment (creatinine clearance ≤ 30 ml/min) should be treated with caution and receive no more than 5 mg once daily (see Section 5.2). _Patients with hepatic impairment _ No dose adjustment is necessary for patients with mild hepatic impairment. Patients with moderate hepatic impairment (Child-Pugh score of 7 to 9) should be treated with caution and receive no more than 5 mg once daily (see Section 5.2). _Potent inhibitors of cytochrome P450 3A4 _ The maximum dose Przeczytaj cały dokument